A Busy Few Weeks in Vaccines
Catching up on the latest vaccine policy developments and what to expect as we head into Summer.
As I’m catching back up on posts after a brief break, I feel like I’ve missed out on discussing quite the volume of developments in vaccines. The past couple of weeks have me feeling a bit like Liz Lemon.
So, with that, let’s talk about it:
Novavax Finally Approved… with Conditions
Just yesterday, AP reported that the Food and Drug Administration (FDA) approved Novavax’s COVID-19 vaccine, albeit with certain restrictions. If you recall, earlier in April, the agency missed the vaccine’s original approval date, stating it was delaying approval while it requested additional data, later requiring Novavax to conduct another randomized-controlled trial.
However, breaking from existing approvals for other COVID-19 vaccines, this product’s full approval only applies to adults aged 65 years and older, and individuals aged 12 to 64 years with “at least one health problem that puts them at increased risk from COVID-19.” This appears to align with certain perspectives among members of the Advisory Committee on Immunization Practices (ACIP) who, in their public meeting last month, raised the possibility of a risk-based recommendation for all COVID-19 vaccines for the upcoming respiratory virus season.
The ACIP has not typically made recommendations that differ from a product’s FDA-approved label - historically, if they do, these recommendations have been narrower than the label, not broader - so this approval for Novavax could set precedent that applies to recommendations for all COVID-19 vaccines. Alternatively, the ACIP could make different recommendations for different products, but it’s unclear how likely this is given their consideration of a risk-based recommendation. The ACIP will vote on its recommendation at its next meeting in June.
Incoming FDA Vaccine Development Guidance
Relatedly, this week, FDA Commissioner Marty Makary announced that the agency was developing new guidance for industry on annual COVID-19 vaccine updates. This comes about a week after the appointment of Vinay Prasad to lead the Center for Biologics Evaluation and Research (CBER), the FDA Center in charge of reviewing and approving vaccines. It’s not clear exactly what will be included in the new guidance, but previous statements could indicate what manufacturers might expect - a couple of weeks ago, a spokesperson from the Department of Health and Human Services stated to the Washington Post that “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.” This could suggest new guidance may require COVID-19 vaccine manufacturers to conduct randomized-controlled trials for annual vaccine updates to some extent, potentially even requiring the use of placebo controls.
Thus far, all signs point toward applicability only to COVID-19 vaccines - the same HHS spokesperson also told Washington Post that the influenza vaccine had been “tried and tested for more than 80 years,” for example - but this will be an area to watch as other seasonal respiratory vaccines, like those for RSV, explore future additional dose administrations.
Some ACIP Recommendations Still In Limbo
The ACIP voted on recommendations for meningococcal, RSV, and chikungunya vaccines during its April meeting; however, before the Committee’s recommendations are considered official policy, they must be endorsed by the HHS Secretary. This authority has historically been delegated to the Director of the Centers for Disease Control and Prevention (CDC), but we still don’t have one - Susan Monarez, who was the acting Director, was subsequently nominated to direct the agency. As the nominee, she cannot serve as acting Director, and no one has been named in her place. Therefore, all ACIP recommendations must be endorsed by Secretary RFK Jr. himself.
As of May 13, the Secretary officially endorsed the chikungunya vaccine recommendation, but meningococcal and RSV vaccine recommendations remain under review.
There were recent reports that an aide to Secretary Kennedy, William “Reyn” Archer III, was tasked with reviewing the ACIP’s recommendations and had requested additional details specifically about the need for an expanded indication for RSV vaccines. It is unclear if this is the reason for the hold up, but it aligns with questioning from the FDA’s new ex officio representative to the ACIP Tracy Beth Høeg, who voiced skepticism of several products’ study designs during the meeting.
Health Portion of Budget Reconciliation Bill Advances
The House Energy & Commerce Committee this week voted to advance its portion of budget reconciliation legislation, which included significant cuts to Medicaid that the Congressional Budget Office estimates could cause approximately 8 million individuals to lose their insurance coverage. I’ve previously discussed how Medicaid cuts could further reduce vaccine uptake; in sum, vaccination rates are lower among Medicaid enrollees than among individuals with private insurance coverage, but vaccination rates are lowest among the uninsured. More uninsured people = fewer vaccinated. Moreover, with less funding to go to state Medicaid programs, these programs will be limited in their ability to conduct crucial community outreach aimed at increasing vaccine awareness and demand.
While the legislation has passed out of committee, it must be voted on by the full House of Representatives. It is likely the bill will be revised to some extent before the vote takes place, as there is still quite a bit of pushback on proposed Medicaid cuts, including from Republican lawmakers.
So, what’s next?
The annual Congressional appropriations process has been officially kicked off by the release of the President’s “skinny budget” request. We’re still waiting on the full budget request and several agency justification documents to understand how exactly the requested funds will be used, but the “skinny budget” indicated sweeping cuts across HHS. Earlier this week, the House Appropriations and the Senate Health, Education, Labor, and Pensions (HELP) Committees held budget hearings with Secretary Kennedy. This coming week, the Senate Appropriations Committee holds two key hearings to watch:
May 20, 10:00am ET: A Review of the President’s Fiscal Year 2026 Budget Request for HHS
May 22, 10:30am ET: A Review of the President’s Fiscal Year 2026 Budget Request for the FDA
Also this coming week, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets to review surveillance data and determine the COVID-19 vaccine strain composition for the 2025-26 respiratory virus season. This Committee has historically focused largely on the data, but we may get insight into the potential implications of new COVID-19 vaccine development guidance, though it’s unlikely we will see the guidance itself before the meeting.
As I mentioned above, the ACIP meets on June 25-27 to discuss and vote on a potential list of 8 vaccine recommendations, including for 2025-26 COVID-19 vaccines.